Method and Apparatus for Verification of Clinical Trial Adherence

ABSTRACT

A system and method of confirming administration of medication in a clinical trial is provided. The method comprises the steps of receiving information identifying a particular medication prescription regimen in accordance with the clinical trial, determining one or more procedures for administering such prescription regimen and identifying one or more activity sequences associated with such procedures. Activity sequences of actual administration of such prescription regimen are captured and then compared to the identified activity sequences to determine differences therebetween. A notice is provided if differences are determined.

FIELD OF THE INVENTION

This invention relates generally to patient compliance in clinical drugtrials and more particularly to the monitoring, instruction andintervention of patients in clinical trials in order to improvecompliance with required drug protocols in accordance with those trials.

BACKGROUND OF THE INVENTION

Dr Lars Osterberg, M.D. and Dr, Terence Blaschke have reported in theNew England Journal of Medicine, Adherence to Medication, (N Engl J Med2005; 353:487-97) 2005 an alarming lack of adherence to requiredmedication protocol, further noting that while the average rates ofadherence in clinical trials is categorized as “high”, this number stillcomprises only rates of 43 to 78 percent. Most importantly, the authorsnote “The ability of physicians to recognize nonadherence is poor, andinterventions to improve adherence have had mixed results.” Adherence,p. 487. The authors conclude “Poor adherence to medication regimens iscommon, contributing to substantial worsening of disease, death andincreased healthcare costs.” Adherence, p. 494. The Trend Repot Series,2008 Patient Adherence Update: New Approaches for Success. October 2008,report similar discouraging statistics. This broad range may possiblycontribute to the public confidence in the FDA approval process and theimportance of continued surveillance of a drug throughout the process.Furthermore, it may help to explain why, according to the Journal of theAmerican Medical Association (JAMA May 1, 2002), one out of every fivenew drugs that comes to market in the US is found to have serious orlife-threatening adverse effects—unknown or undisclosed at the time ofapproval. It is against this backdrop of poor adherence, and potentialdanger to patients, that the present invention operates.

It has been widely recognized that methods and systems for insuringproper medication ingestion or administration by individuals are veryimportant in defending against unnecessary sickness, deaths and otherproblems. Giving instructions and then letting patients fend forthemselves has been shown not to work particularly well. This is becauseit is not only the improper ingestion of medicines that is the primarycause of medical danger. Rather, an overall lack of sufficient patientguidance is also part of the problem. Further, the inability to confirma proper prescription regimen being provided to a user in the firstplace may cause a number of other problems with the use of suchmedication.

These issues are even more problematic in a clinical trial setting wherea lack of adherence to a particular assigned protocol may influenceeventual approval of a particular drug therapy, potentially denying avaluable drug to the public and resulting in possible rejection of drugsthat should be on the market that have been backed by pharmaceuticalcompanies for hundreds of millions of dollars. Additionally, failure toadhere to prescribed protocols in clinical drug trials may result inpoor data collection and evaluation, thus resulting in the abovementioned deaths from failure for trials to identify potentiallylife-threatening side effects. Poor adherence to prescribed protocols inclinical drug trials may refer to any deviation in a patient's behaviorfrom that recommended by the trial designers, including, in addition toimproper medication administration, improper timing of administration,such areas as dietary advice, advice on smoking, or even advice aboutattendance for further investigation or follow-up. Specifically inclinical trials, any such poor pharmaceutical compliance by the patientmay result in inadequate results or outcomes.

Corrupt or incomplete clinical trial data, inefficiency in followingdrug regimens and the inherent liability involved with clinical trialsfurther complicate an already time consuming, complex, and expensiveapproval process which may take between 8 to 12 years and cost over $900million. Even after the initial clinical trial testing has beencompleted, there is generally no system for monitoring further use inPhase IV testing, or monitoring patients after launch. Given thepossibility of failure of the clinical trial testing to ensure drugsafety, such additional testing may be quite important. Inherent to theclinical trial process are a number of common mistakes that have not yetbeen addressed with existing clinical trial protocols.

Traditionally, participants attend introductions and follow ups forclinical trials in-person. Data collection is similarly limited topatient visits, rather than on a daily basis. Old methods such aspatient questioning and pill counting have been proven to be inadequatemeasures of adherence and offer no information on dose timing and drugholidays (omission of medication for three or more sequential days).

Compliance technologies can increase the statistical power of clinicaltrials. Through the use of such technology, clinical events can beprecisely linked to medication use history. Captured data can be linkedto other sources such as EDC, patient diaries and data collected by thephysician. Technologies can create many possibilities for remote visitsand data capture. While smart packaging technologies exist such asRFID-enabled computer chip technology, smart blister packs and MEMS caps(microprocessor in a bottle cap), they are: a) invasive and need to bephysically attached to the medications; b) are non-conclusive regardingcompliance—a patient may activate the technology without ingestion ofthe medication; c) remain largely unadopted in clinical trials by thepharmaceutical and biotech companies due to their high cost; and d) takea longer time to implement.

Jo Carol et al. stated that “The most reliable method for researchpurposes, although not practical in a clinical setting, may be acombination approach that includes pill counts, patient self-report, andelectronic monitoring.” (Carol J. et al, Patterns to AntiretroviralMedication, The Value of Electronic Monitoring, AIDS, 17 (12), pp 1,763-767, October 2003. To date, technologies alone have only been usedto monitor compliance rather than to encourage it. Furthermore, therehas been no comprehensive system provided that allows for the managementof multiple patients and multiple patient populations. While currenttechnology may allow poor compliers to be recognized, as will bedescribed below, the proposed system of the present invention will helpto encourage pharmaceutical compliance and tackle some of the problemsthat are encountered in the clinical trial process.

Another problem is the issue of informed consent and the protection manyclinical trials attempt to implement, often unsuccessfully, to protectthemselves from potential lawsuits. A survey was conducted byCenterWatch (Getz, K. A. (2002). Informed consent process: A survey ofsubjects assesses strengths and weaknesses Applied Clinical Trials,11(11), 30-36) to assess subjects' understanding of the consentdocuments further supports the concept that patients may not understandthe forms they are signing. The survey reported that 14% of patientssigned a consent document without reading the form. In the same survey,30% of patients reported that they did not understand that their trialcould carry more risk and discomfort than standard treatment. Nearly 40%of patients did not know that they could call an ethics board or IRBrepresentative with questions about problems or concerns. The surveyreported that 41% of patients did have study nurses review the consentform with them. The survey finally concluded that 70% of theparticipants may not have known what questions to ask at the outset ofthe informed consent process. And, this is with the current informationprovided and consent received from these participants. Withapproximately 77,967 trials in as many as 172 countries registered withClinicalTrials.gov as of the date of this application, the logisticalchallenge of ensuring consistency is overwhelming.

In patients with psychiatric illness, adherence may be even moredifficult and technology solutions such as the one proposed inaccordance with the present invention may offer accurate ways toauthenticate adherence. According to Cramer and Rosenhek (Compliancewith Medication regimens for mental and physical disorders, PsychiatrServ 1998), among patients with physical disorders, the mean rate ofmedication adherence was 76%, whereas among those with psychoses themean rate was 58% and among those with depression the mean rate was 65%.Similar compliance issues might be expected to be present when dealingwith child patients, or others who may have difficulty followingpotentially confusing instructions.

The logistical challenge of medication adherence and auditing inclinical trials is certainly increasing, with more than 70,000 clinicaltrials under way throughout the world, growing at a rate of 8 to 10percent a year, according to CenterWatch in Boston, which lists clinicaltrials. In 2003, there were 3.6 million individuals enrolled in clinicaltrials in the United States, according to the center. Self-regulation inthe industry is necessary as the FDA inspected only 1% of clinical trialsites during the 2000 to 2005 period (Department of Health and HumanServices, Food and Drug Administration's Oversight of Clinical Trials,September 2007). As the requirements for drugs increase, one can expectthat the ability for the FDA to inspect such clinical trial sites todecrease even further. Furthermore, the average cost of $6533 to recruita patient for a trial, and three times that amount to recruit a newpatient if one is lost due to noncompliance is high so pre-screeningsubjects and monitoring them on an ongoing basis is critical. Thesenumbers are significant given the fact that it has been calculated thatif 30% of patients in a clinical trial had inadequate compliance, doublethe number of patients would need to be studied to create the same alphaand beta levels (Pledger G W. Compliance in clinical trials: impact ondesign, analysis and interpretation. Epilepsy Research 1988; 2 (suppl):125-33).

Tufts CSDD Impact Report stated that within three years, major sponsorsproject that up to 65% of FDA-regulated clinical trials will beconducted outside the U.S.—primarily in Central and Eastern Europe,Latin America, India, and Asia—due to economic advantages and readyaccess to well-trained physicians and large numbers of treatment-naïvepatients. In addition, contract clinical services account for more than17% of total drug development spending. The growth of sponsor spendingon CRO (Clinical Research Organization) services will outpace overallgrowth in spending on global drug development for the foreseeablefuture, reflecting increasing reliance on contract providers to provideadded capacity, more flexibility, and greater efficiency.

With greater amounts of clinical trials being conducted abroad,technology can aid standardization and provide greater communicationwhere deficiencies in existing infrastructure such as physician andnurse training, may exist.

A number of systems exist that provide instructions to a user regardingwhen to take a medication and records when the user indicates that amedication has been taken. U.S. Pat. No. 7,359,214 describes such asystem. A device is provided that provides instruction to a patientregarding medications to take. Furthermore, the system may provide amethod for determining that the prescription is appropriate given thepatient's conditions, and other medications he or she may already betaking. The system may monitor the dispensing of medicine in accordancewith a predetermined treatment protocol. While such a system providesmany improvements for easing a burden on the patient, this systemsuffers in many ways and in particular in ways relevant to theadministration of clinical trials.

Most importantly, this system provides no mechanism for actuallyconfirming that a patient is in fact ingesting or otherwise properlyadministering required medication as required in a clinical drug trial.While the system may be sufficient for one who is in full possession oftheir mental faculties, any individual who may have difficulty followingdirections, or one who is actively avoiding medication may still not betaking required medication after it is dispensed. Thus, participants maybe forgetful, visually impaired, or otherwise do not believe in thebenefit of taking such medication, and may thus not properly logmedication administration. Furthermore, the system requires preloadingof various medications into a dispenser, and thus likely requiresregular visits by an administering manager to be sure appropriatemedications are in fact properly loaded therein. It is surely possiblethat an inexperienced user may place incorrect medications into thedevice, or may somehow provide incorrect dosages into the device.Additionally, for potentially more complex regimens, there is no methodprovided for insuring that a user is able to follow such a protocol, andto thereafter confirm that the user has in fact taken all requiredmedications in accordance with any provided instructions or the like, orhas taken the medications according to one or more specifications orfollowed suggested procedures. Furthermore, this system is expensive andrequires constant maintenance to confirm that the various mechanicalparts are in working order.

U.S. patent application Ser. No. 11/839,723, filed Aug. 16, 2007, titledMobile Wireless Medication Management System provides a medicationmanagement system employing mobile devices and an imaging technology sothat a user is able to show a pill to be taken to the system, and thesystem can then identify the medication. Patient histories are availableto an administrator, including various vital signs as measured by thesystem. Images may also be taken of the patient, provider, medicationcontainer or the like. While the system professes to ensure adherence toa protocol, the system only provides such help if requested by a user.There is in fact no particular manner in which to ensure actualadherence or the relationship of adherence to the efficacy of the drugover time. When requiring adherence to a predetermined protocol for aclinical trial, this is particularly relevant.

Additionally, existing systems fail to maintain an audit trail for postadministration review by a medical official or other clinical trialadministrator, and further cannot therefore confirm confirmation ofproper medication administration.

Therefore, it would be desirable to provide a method and apparatus thatovercomes the drawbacks of the prior art.

SUMMARY OF THE INVENTION

In accordance with the present invention, a system and method areprovided that allow for complete control and verification of adherenceto a prescribed medication protocol or machine or apparatus use in aclinical trial setting, whether in a health care provider's care, orwhen self administered in a homecare situation by a patient.

The present invention is intended for the clinical trial market as afull audit and tracking tool for pharmaceutical compliance in subjects.The invention provides the only medication management system that maydetermine whether a user is actually following a protocol, provideadditional assistance to a user, starting with instructions, videoinstructions, and the like, and moving up to contact from a medicationadministrator if it is determined that the user would need suchassistance. Upon prescription of a medication to a user in a clinicaltrial, the trial designers may then select a desired protocol for theuser to follow, and therefore, not only may a particular drug be tested,but also test the ease of adherence given a particular set ofinstructions.

In recent years, the United States Department of Health and HumanServices, Office of the Inspector General (“OIG”) has issuedpublications to make it clear to members of the boards of directors ofhealth care companies conducting business with federal health careprograms (directly or indirectly) that these fiduciary duties include anobligation at the board level to assure that the health care companymaintains an effective corporate compliance program. Due to increasedcompliance obligations by the office of the inspector general (OIG),chief compliance officers of pharmaceutical companies must, to best oftheir knowledge, ensure that their company is compliant with anyrequired regulations. Failure may result in personal liability. Thus,the ability to maintain an audit trail in a clinical trial setting mayaid in meeting these requirements.

The novel combination of text, graphical, pictorial, and video allowsthe compliance problem within clinical trials to be tackled in aholistic manner. The system in accordance with the present inventionoffers a number of solutions. First, the system helps to ensure that thepatient is giving informed consent. The system and method may providestep-by-step image and video instructions to the user or care provideron how to administer the medication, what the side effects of themedication are and the benefits that have been found. This avoidsmisunderstandings resulting from prescribing instructions and may allowan approach that may be utilized internationally, thus overcomingpossible language barrier issues and the like.

A specific medication regimen may be programmed into a medicationcalendar to alert the user when medication should be taken and provideclear video instruction for taking the medication. These remindersminimize forgetfulness by the subject in clinical trials and help thelogistical challenges involved in complex medication regimen such asdouble blind studies, for example. Furthermore, the medication calendarand the compliance results are accessible to the clinical trialorganizers.

Once an alert is made and the patient has confirmed that they are readyto take the medication, the system and method of the invention recordthe type of medication and quantity through image recognition. Thesubject shows the medication to an imaging device which thenauthenticates the medication if in the correct dosage and offeradministration instructions. Other types of recognition of the bottlesmay also be used, including RFID tags, bar code reading, textrecognition, or other confirmation through a provided graphical userinterface, preferably in conjunction with the image recognition. Oncethe medication type and quantity has been authenticated, the system andmethod of the invention records or otherwise visually analyzes thepatient actually administering the medication to him or herself, usingany of the above recognition methods, and further including facialrecognition, badge identification, or any other method for confirmingthe identity of the individual. A real-time log for audit trails andfurther analysis is thereby created. Additional information may becaptured using a brief questionnaire on the device which may help tohighlight problems when administering the medication—such as difficultyin swallowing tablets or opening packages—or adverse reactions fromwhich the patient is suffering. Whatever the reason a patient misses areminder or medication prompt, the system and method of the inventionalerts the clinical trial organizers. Data from all the population canbe captured and presented in an aggregated manner online in real-time,giving real-time data results and flag problems or results early.

As clinical trials begin, it will quickly become evident if a clinicaltrial is designed well and difficulties or non-compliance will behighlighted by the system and method of the invention. Ofteninconvenient or restrictive precautions prevent the medication regimenfrom being followed accurately and this type of feedback can be veryuseful. The system of the invention minimizes delinquent or inaccuratedata submission by linking clinical events to medication use. The systemalso tracks the actions taken when a problem has been highlighted. Thisaudit trail is then stored. Finally, if a patient is determined to beunable to follow a prescribed regimen, that patient may be identifiedand removed from the clinical trial population, or at least flagged,thus removing a confounding factor from the determination of whether adrug is safe and effective.

The system and method preferably includes a means for receiving usermedication information, including a medication profile and history,providing indications to a user regarding when to take a medication inaccordance with a prescribed regimen in accordance with a clinicaltrial, and which medication to take, imaging medication either in pillor container form to confirm that a correct medication is being taken,confirming, in accordance with the user medication, that a newmedication prescribed in accordance with a clinical trial will notconflict with another medication the user is already taking (includingnon-prescription medication that may be used by a patient), scan a groupof medication containers or pills to inform a user which is the correctmedication through the use of visual, verbal or other prompts, providingassistance information to aid a user in properly taking the medication,imaging, employing still photos, video sequences or other activity orgesture recognition techniques, the user to confirm that the medicationis being actually and properly taken, providing any appropriateadditional or special instructions so that the user is able to complywith the instructions of the clinical trial, using the imaging to noteany possible adverse effects associated with taking of the medication,accumulating statistics about adherence to a prescribed protocol,assisting in reordering medication on an as-needed basis and notifying aclinical trial manager if the user is not properly following aprescribed protocol. If desired, a patient's face or other identifyingfeatures may be hidden so that the recorded sequences may be stored,displayed and otherwise used without allowing the identity of anyparticular patient to be released.

From beginning to end, a user is provided with a system and method thataids the user in properly following a protocol as defined in a clinicaltrial setting, while informing an administrator of any deviations fromthe protocol, either innocent or purposeful, by a user so that an earlyintervention may be provided. The present invention is the only clinicaltrial medication adherence verification system that may determinewhether a user is actually following a protocol, and provide additionalassistance to a user, starting with instructions, video instructions,and the like, and moving up to intervention from a medicationadministrator through phone, email video conferencing or the like, if itis determined that the user may benefit from such assistance. Throughsuch improved provision of care, potential clinical trial participantsmay be more likely to participate in such a clinical trial. The systemmay also identify individuals to be removed from a clinical trialpopulation, and also possibly identify sets of instructions that may notbe working to get people to follow the prescribed regimen.

Still other objects and advantages of the invention will in part beobvious and will in part be apparent from the specification anddrawings.

The invention accordingly comprises the several steps and the relationof one or more of such steps with respect to each of the others, and theapparatus embodying features of construction, combinations of elementsand arrangement of parts that are adapted to affect such steps, all asexemplified in the following detailed disclosure, and the scope of theinvention will be indicated in the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the invention, reference is made tothe following description and accompanying drawings, in which:

FIG. 1 is a flow chart diagram depicting top level functionality inaccordance with an embodiment of the present invention;

FIG. 2 is a flow chart diagram describing a data entry and prescriptionassignment process in accordance with an embodiment of the presentinvention;

FIG. 3 is a flow chart diagram describing a medical compliance regimenfrom in accordance with an embodiment of the invention:

FIG. 4 is a representation of a summary page of a dashboard inaccordance with a preferred embodiment of the invention;

FIG. 5 is a representation of a zoomed in view of the summary page ofFIGS. 4; and

FIG. 6 is a representation of information provided in accordance with anindividual clinical trial participant indicator in accordance with apreferred embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In accordance with the invention, a system and process are provided thatimprove adherence to medical protocol in a clinical trial setting, andgive administrators a tangible and concrete manner in which to confirmcompliance or lack thereof, and the ability to intervene early in theprocess to ensure that patients enrolled in such a clinical trial studyare properly taking their medication. The system and method of theinvention provide for instructions to patients on the use of theprescription medication under trial, verification to a doctor or otherservice provider of patient adherence to the prescribed protocol, andstatistical and individual analysis of adherence rates to ensure properclinical trial administration. The system and method further improve alevel of care received by a patient in a clinical trial, and othersetting, as well as improve the perception of that level of care by thepatient. The system and method of the invention further provide theability to track adverse events in a clinical trial or other setting,thus allowing for these events to perhaps be correlated with otherevents to aid in determination of the effectiveness and/or potentialdanger of a particular drug that is the subject of the trial.Furthermore, the clinical trial management application in accordancewith this invention is contemplated to be equally applicable to thetrial of medical devices or other apparatuses, as well as any method oadministration of medication, including ingestion, injection, topical orother appropriate delivery method.

Referring first to FIG. 1, a data flow overview is shown. In accordancewith the invention, information about a particular drug to be thesubject of a clinical trial is provided in a database 105, and existingindustry medication information databases 110 are employed to accessprescription, interaction, application and other available informationabout any number of proposed prescription and non-prescriptionmedications and their possible interaction with the clinical trialmedication. Further, patient medical records 115 are used, and as willbe described below, are used in conjunction with the industry medicalinformation and a medical professional's prescribing expertise toconfirm that a patient is a good candidate for such a clinical trial.Once confirmed, a medicine regimen in accordance with the clinical trialrequirements is prescribed and entered into the system of the inventionat 120. Once entered into the system, a particular prescription regimencauses a set of user instructions 125 to be generated. In accordancewith the clinical trial, such instructions may be varied for differentusers to determine the best set of instructions, or may be varied basedupon demographics, experience, or other factors that may requiredifferent types of instructions to be provided. It is furthercontemplated in accordance with the invention that multiple clinicaltrials may be managed by a manager in accordance with the invention sothat the invention contemplates a clinical trial administration systemthat allows for a single point of management for all clinical trialsassociated with a particular manager or the like.

Such user instructions may include general instructions about theparticular medication subject to the current trial, methods foringestion, warnings about side effects, concerns about drug interactionswith common substances or medications, or other medications prescribedto the patient by the system or by another medical service provider. Itis contemplated in accordance with the invention that such set of userinstructions may be interactive, allowing a user to view additionalinformation about such instructions or prescriptions as desired. Theseinstructions may comprise written, audio or video instructions.Furthermore, it is contemplated in accordance with the invention that atvarious points during the instruction set, for example when a patientasks a particular type of question, or asks to receive additionalinformation about a particular aspect of the medication or prescriptionregimen, that the system may reach out and contact a representative of amedical service provider to provide the patient with additional,personal help as necessary, if it is determined that such interventionby the medical professional would be desirable to the patient. Thus,such a patient may be assisted in properly taking medication so thatvarious errors do not take place. Indeed, in more traditional scenarios,it is only after perhaps finishing a prescription regimen and a returnto a doctor in accordance with a predetermined clinical trial schedulethat it is discovered that the medication may have been takenincorrectly. In accordance with the present invention, earlyintervention with such issues can be exercised to deter any possibleunfortunate outcomes from improper administration of medication, and toensure that the particular patient is able to remain in the study andprovide accurate data to the study.

It is contemplated in accordance with the invention that a clinicaltrial manager is provided with a patient dashboard for managing regimesfor one or more of the patients taking part in the clinical trial, andas noted above, for managing multiple clinical trials taking place andmanaged by the particular manager. Such a dashboard allows the clinicaltrial manager to monitor any number of patients in a manner that will bedescribed below, allow statistical analyses of patient adherence andother patient reactions, provide links to information, includingrecorded activity sequences for one or more patients, record and be madeaware of any adverse events taking place during the trial, and generallyallow the medical professional to monitor and administer medication toall of trial participants from a convenient single access point. Such adashboard also allows for monitoring of any health care providers thatmay be administering medication to a number of the clinical trialparticipants, or review of one or more administration sequences or thelike.

Additionally, it is contemplated in accordance with the invention thatthe patient is provided with a user interface dashboard or the likeallowing of modification of prescription regimen and instructioninformation by the patient, limited of course to within guidelinesestablished by the prescribing medical provider. Thus, by way ofexample, if a user is to take a particular medication before eating inthe morning, the user may be able to determine when a reminder for suchmedication will be given. If the patient is an early riser, the remindermay be provided by cell phone or email at 6:00 AM. Conversely, if thepatient sleeps late and normally does not eat an early meal, reminderscan be set for later in the morning, thus matching a patient's schedule.Of course, any such patient adjustments must be set within broaderprescription regimen as defined by the prescribing medical provider.These requested modifications may give additional information to thetrial managers regarding easier protocols for drug administration, ormay lead one to investigate a particular individual for non-adherence tothe trial protocol.

It is contemplated in accordance with the invention that a touch orother user friendly graphical user interface be provided so that theuser can easily manipulate any number of prescription factors, andperhaps enter additional information that may be useful to a prescribingmedical provider, such as level of fatigue, level of hunger, jitterinducing medications, etc. All of these data collection points allow fora smoother administration of medication to a patient, and therefore amore likely chance of adherence to a prescribed protocol.

Referring to the lower portion of FIG. 1, the horizontal line indicatesa time for patient ingestion or other administration of medication. Thepatient may display a medication container and/or an actual pill orother medication form to an imaging apparatus, and the apparatusconfirming that the medication is correct and is the currentlyprescribed medication to be taken through the user of text recognition,pill recognition, or other appropriate medication recognition scheme.This sequence of steps therefore acts as an audit trail each time amedication is taken, that can be reviewed later, to ensure that apatient is properly following a regimen.

In accordance with the invention, confirmation of patient adherence tothe prescribed administration schedule for the medication as prescribedby the clinical trial regimen is determined. While such confirmation maytake a number of forms, in accordance with the invention, a preferredmethod for such confirmation may include capturing a video sequence ofthe patient actually administering the medication. In a furtherpreferred method, such a sequence for such confirmation may includeemploying a facial recognition sequence or other biometric confirmationthat a particular patient is in fact receiving treatment, but may alsoprovide for the ability to obscure the face or other identifying featureof a user to allow for the storage and use of such images whileprotecting the identity of the patient, a technique that may bebeneficial when a manager is providing a general report about theclinical trial, and not trying to remedy a situation with a particularpatient. Activity recognition, gesture recognition or other feature fordetermining whether a particular subject movement meets a predefinedmovement sequence may be employed to be sure that the patient isproperly taking prescribed medication.

Furthermore, in accordance with the present invention, a video image ofthe patient actually administering or ingesting the medication may betaken and stored so that actual confirmation may be achieved, ratherthan simply relying on the patient to state that a particular medicationwas administered. Such a video image may be captured or stored in anyappropriate format given a selected type of activity or gesturerecognition that is employed in accordance with a particular embodimentof the invention. Such may include full video, biometric data points,recording of movement of an article, such as a bracelet or the like,affixed to the patient or administrator, use of mapping to provide astick figure or other body movement tracking technique, or gesture oractivity recognition to determine movement or the like. The user may beencouraged to use a particular sequence of movement to be confirmed thatthey are properly administering the medication according to theprotocol, thus reducing the possibility of the potential appropriatemovements considered to be “correct.” Indeed, various instructionalvideos or other appropriate training may be provided to a user to insurethey properly administer the medication. Finally, in accordance with theinvention, if recording of a video of a patient having the medicationadministered thereto is not possible, the system of the invention willrecognize such an issue and request audio confirmation as a next bestoption. If the audio confirmation is also not possible, then a lessreliable method of confirmation, such as a keyboard confirmation by thepatient may be accepted. If higher reliability methods of confirmationare not available for an extended period of time, an alarm is preferablyforwarded to a medical professional to inquire as to reasons and toremedy any situation that might be wrong in the administrationsituation.

These steps of confirming identity, confirming medication and confirmingadministration are then reviewed to verify adherence to the prescribedprotocol at 135. Such review is preferably performed automatically by acomputing system that is able to align the actual recorded images withideal or expected images, or through the user of other activity orgesture recognition as mentioned above. In the case of facialrecognition and bottle or pill recognition, such techniques are known inthe art. With regard to video confirmation of adherence to prescribedmedicine administration procedures, such processing may include variousstick figure comparison analyses, activity recognition analysis, orother schemes as noted above able to determine whether appropriateactions have been performed by the patient.

The ability to provide automated determination of adherence to properadministration procedures allows for a large number of such images to bereview in a short period of time. Even if actual and complete lack ofadherence is not able to be determined 100% in each possible situation,the ability to pre screen the administration video captures to removefrom further consideration administration situations that are clearlycompliant may reduce a number of compliance situations to be reviewed bya medical professional substantially. Additional human review ofindications of failure of adherence may be provided, thus insuringproper review of all potentially dangerous situations while greatlyreducing the number of images necessary to be reviewed by a human. Thus,multiple benefits of such an automated system are realized, includingreducing time to review such images, reducing costs of such review, andimproving patient privacy by limiting the number of humans viewing suchdata, while improving quality.

In an additional embodiment of the invention the imaged sequences usedfor activity recognition to determine regimen adherence may be furtherused to check for adverse or other reactions to taking of themedication. Thus, in addition to simply determining proper adherence toa protocol, such activity or gesture recognition may determine anynumber of different actions that may have been taken by a patient. Thus,actions taken before medication administration, or actions taken aftermedication administration may give insight into reasons for particularresponses, etc. Thus, before administration, in accordance with theinvention, activity recognition may determine a current activity of auser. Any subsequent reminders to take a medication may in part be basedupon this determined activity. By way of example, if a user is puttingon a coat, or is determined to be leaving a residence or other facilityor the like, a reminder to take a medication before leaving may beprovided, even if earlier than normal, or if medication is portable, theuser may be reminded to take the medication with them, and thensubsequently reminded to administer the medication via notification on amobile device. By way of further example, if the user is cooking, areminder may be given to take the medication a predetermined time beforeeating. Other scenarios may be possible, thus allowing greater responsefrom the system to ensure proper medication administration by a patient.Additionally, various patient consent issues may be prompted andrecorded in accordance with the invention. Patients may ask furtheradditional questions regarding such consent, thus insuring that patientshave all of the information they need to make informed consentdecisions, and medication providers have proper evidence of suchconsent.

Similarly, actions after taking medication may give insight into patientresponses. Notice of fainting, falling down, lack of motion, facialgestures, gastrointestinal distress or the like may all be logged asadverse reactions to a particular medication regimen, and may allow foradjustment of dosage or prescription instructions in the future for thepatient. If adverse reactions are severe, an immediate medication reviewand contact from a medical professional may be provided to cure theissue. Additionally, the system in accordance with the present inventionmay be directly tied and be interoperable with a pharmacy or medicalprovider's systems as administered by the clinical trial manager, thusallowing such recommendations for dosage changes, regimen changes andthe like to be forwarded to these professionals automatically. Throughsuch links, reordering medication, dosage changes, medication changesand the like may be automatically provided. Furthermore, ease ofproviding additional prescriptions can be enhanced as patient,medication and regimen information will already be available to thepharmacist or medical service provider.

After such automatic, or combination of automatic and manual, adherenceverification is performed allowing a health care provider or othermedical professional to review and verify results of the automaticcomparison or direct review of captured activity sequences, andindication of variation from a desired identity, medication orapplication procedure may request administrator review of the situation,and intervention as may be determined necessary at 140. Such review maybe required immediately as an emergency situation may exist, or thepatient may gesture or otherwise indicate that help is necessary, orsuch review may be less urgent, perhaps requiring an electroniccommunication with suggestions or the like from such an administrator orthe like. Additionally, such adherence review may be stored over timefor a particular patient, thus allowing for various medication trends tobe determined, such as if a patient misses medication at a same timeeach week, or an indication that one particular health care workeraiding the patient may occasionally give an incorrect medication dosageamount. Thus, in addition to allowing for immediate notice of problemsin medication administration, an audit trail for tracking the actions ofvarious health care providers is generated. Such an audit trail allowsclinical trial administrators or other medical professional to determineimmediately, or upon review of a complete medication regimen, whether aparticular patient or group of patients has followed the protocol to thelevel that allows their results to be used as part of the study.Additionally, levels of adherence may give insight as to the ease of useof a particular regimen, and whether instructions provided to thepatient are sufficient to allow for adherence to the prescribedmedication regimen.

Therefore, in accordance with the invention as set forth in FIG. 1, amethod and system are provided in which patient adherence to aprescribed medication regimen as set forth in a clinical trial scenariocan be reviewed, acutely for a particular instance, or over time todetermine any changes in behavior of a patient. Because all aspects ofsuch adherence are monitored preferably visually, and do not rely onpatient confirmation of medication administration, desires of thepatient are taken out of the equation, and a true review of actuallyprocedures used in the medication administration can be studied. Trialmanagers are therefore able to keep patients on their prescribedregimens, thus reducing the overall cost associated with the clinicaltrials, and remove patients from the test population when they cannotmaintain adherence to the prescribed regimen, thus increasing theaccuracy and repeatability of the results of the trial. Through themanagement of multiple clinical trials, patient interaction is eased,and any similarities across trials may also be determined, thusimproving quality of care generally and allowing for consistency acrossany number of trials.

Referring next to FIG. 2, a more precise description of the data,medical record and prescription regimen entry will now be described. Asis shown in FIG. 2, a clinical trial manager 202 enters information intoa system in accordance with the invention, and in particular entersinformation regarding medication regimen, dosage, instructions sets andthe like. A patient 206 may also enter information relevant to thepatient. The trial manager 202 may further enter or alter patientinformation, basic medical statistics, and virtually all other medicalinformation included in a database. The patient 206 may be limited toproviding personal information, and perhaps other relevant information,such as non-prescription medication usage, alcohol consumption, recentsymptoms, reaction to use of particular prescription medications and thelike. Such data entry allows for the tracking of an audit trail at thisstep of administration as well. Of course, any of this information maybe automatically entered into a system from a database having beenpreviously entered or otherwise obtained from an existing data storagearea. Also, if particular information is omitted by the patient, or isotherwise unavailable, it might be possible to request provision of thisinformation, or otherwise remove the patient from the clinical trial.Additionally, determination of failure of proper procedure of theinformation collector may be determined so that additional training orremoval of this individual may take place before a large number ofpatients are entered into a clinical trial with insufficient informationcollection.

Information from each user of the system is combined, where available,and formed into a clinical trial medication entry 210. In particular, apreferred list of information that may first be provided in accordancewith the invention in order to organize the system may comprise apatient name, a user name, if that user is not the patient, andinformation to be used to provide various alerts, such as a patientemail for prescription reminders, contact information for a doctor orcaregiver for emergency contact, mailing address for various bulk andnon-urgent communications, and cellular telephone or landline telephoneinformation for patient contact, or the like. Further notifications maybe provided to the trial manager 202 so that the manager can monitorpatient use of the medication and adherence to the proposed andprescribed medication administration. In addition, in accordance withthe invention, facial images of the patient and other people interactingwith the system are stored, or other biometric identifiers, such asfingerprint identification, retinal identification, voice recognition,various provided RFID tags or the like may be employed along with moretraditional passwords and user names or the like. Of course, if thepatient is a returning patient, such information may be extracted froman existing database stored with another, previous prescription.

Next, a user such as the doctor 202 or the pharmacist 204 or nurse, mayindicate a particular new or recurring prescription medication to beprovided to a user in accordance with the clinical trial. An externalmedication database 215 is accessed and information regarding suchmedication is provided, including medication name, suggestions forappropriate prescription dosages based upon patient information and theparticular version of the medication to be administered, and usageinstructions to be provided to the patient, these instructions beingmodified or supplemented as necessary by the trial manager. These usageinstructions preferably include detailed administration instructions,including time of day, patient status (i.e. before or after eating,after waking, before sleeping, etc.), precise method of application, andother useful instructions for a user. These instructions also mayinclude video sequences to describe particular details of the medicationor administration procedure thereof and in order to properly indicategestures to be implemented by the patient. They may also comprisealternative versions of instructions so that if a user is unclearregarding a particular set of instructions, an alternative set ofinstructions may be provided to the patient to aid in adherence to theprescription regimen.

After selection of such a medication, a patient medical history 217 ispreferably accessed to provide additional medication and patientinformation to the trial manager. Such information may include, otherprescriptions to the patient so that adverse drug interaction may bedetermined (although if such other prescriptions were implemented inaccordance with this invention, such prescriptions will already be knownto the system), patient indication of use of non-prescription drugs,patient allergies, patient activity level, past diseases and procedures,and any other information that may be relevant to the prescription ofmedication.

After all of the information has been entered about the user, andinformation from the medication and patient database has beenaccumulated, various medication interactions are checked automaticallyby the system at step 220. Any dangerous interactions are noted to thetrial manager, and may preclude entry of the prescription into thesystem and therefore preclude the particular patient from participatingin the clinical trial. Other interactions may be noted to the trialmanager so that the individual may make the patient aware of suchsituations. These may include, for example a notification that thetaking of two medications together may result in stomach pains, so thatthe patient should take one in the morning and one in the afternoon.Such interactions check will then result in a set of instructions thatwill be provided to the user, in addition to the more generic medicationinstructions. Finally, the trial manager may review such instructionsand supplement them as desired. It should be noted that in accordancewith the invention it is contemplated that various instructions providedto a user may comprise hot links to additional audio and visualinformation that may be provided to a patient to further assist in theiradherence to any particular prescribed protocol, or may provide variousinformation regarding the particular medication being taken as will befurther described below. Such instructions may indicate methods by whicha user is to administer one or more medications, and thus requests useof a particular gesture or the like during administration.

Finally, after all interactions and instructions have been reviewed andapproved, the prescription information is stored at step 225. Thestoring of such a prescription makes the prescription, alerts, helpinformation and the like accessible to a patient and other system users.Furthermore, such completion may also transmit the prescription to apharmacy or other medication provision facility so that the user is ableto simply swing by to pick up the medication or to have the medicationdelivered to the patient.

Referring next to FIG. 3, a user implementation of the method inaccordance with the invention will be described. When a time forreceiving or administering a medication in accordance with a clinicaltrial regimen is reached, a patient, and any other necessary user may beprovided a notification 310 in accordance with notification addressesentered in the system as noted above. Thus, in a home situation, onlythe patient may receive notification. If there is a home health careprovider, such provider may also receive separate independentverification. In the case of hospital or other in-patient care facility,various medical service providers may similarly receive suchnotification. After notification, or in the absence of suchnotification, system initiation takes place at 315. In accordance withsuch system initiation, one or more users are preferably recognized bythe system. Therefore, at step 320, a user recognition sequence takesplace. In a preferred embodiment, such a user has a still or video imagecaptured of their face, and facial recognition techniques are employedto confirm the identity of the user. Such capture may be performed byfixed camera, mobile camera, mobile communication device such as acellular phone, or any other appropriate video or image capture device.Alternative recognition techniques, such as retinal, fingerprint, voiceor other biometric measurements may be employed, in addition to a morecommon password query. Any other appropriate identification techniquemay be employed, and any unique individual identifiers may be obscured,as noted above, when the images are to be used as a more general reportregarding adherence, rather than an individual patient response.

At step 325 it is determined whether all necessary users have beenrecognized and authenticated. In a situation where a nurse, doctor orother caregiver is to administer medication, it may be preferable tohave the patient and caregiver to be recognized by the system to furtherconfirm that the appropriate procedure is followed, and to allow thesystem to keep track of people using the medication so it can track ifany one person, for example, is improperly using the medication, as willbe evident from the generated audit trail. After step 325, if all usersare not recognized, control passes back to step 320 and any additionalusers are recognized by the system.

Once all users are recognized, control passes to step 327 where themedication to be administered in accordance with the prescribedprescription regimen of the clinical trial is confirmed. Thus, a user isprompted to allow a still or video image, text recognition image, orother method of identifying a medication to be captured of themedication bottle or other container, a pill of the medication, or otherform of medication, and is also able to determine appropriatequantities, dosage, and any potentially required or dangerous medicationcombinations. As noted above, if video confirmation is for some reasonnot available, the user may be prompted by the system to provide audioor other indication of medication and other desired information. Thisimage, video sequence or other received confirmation information is thencompared to an image associated with the prescription as noted above inFIG. 2. If the medication is determined to be incorrect, a warning maybe provided to the user that the medication is incorrect. The user maythen be prompted to choose another medication for imaging.

Alternatively, the invention contemplates a user displaying a number ofmedications to the image capture apparatus and allowing the apparatus tosuggest which medication is correct. Thus, the user may be able to scana medicine cabinet with such a video imaging apparatus and have thesystem indicate which is the correct medication. This may prove valuablewhen sequence of ingesting medication is important, or when two peoplehave similar medications and may have difficulty in distinguishingbetween medications for each. Once a correct medication has beenidentified, control passes to step 330.

In step 330 user prompts and other instructions are provided to thepatient, and present caregivers, as to how to administer the medicationaccording to the prescription guidelines outlined above as determined inaccordance with the particular clinical trial under consideration. Theseinstructions allow for a user to receive further information orinstructions as necessary through asking the system for additional help.Especially in situations where an elaborate scheme may be required, itis contemplated that video samples and instructions may be provided tothe user. Further, in accordance with the invention, for complicatedadministration procedures, it may be possible to set up a two way videoconference employing traditional video conferencing, VOIP conferencing,traditional telephone conferencing, or any other appropriatecommunication system with an expert in such administration so that acaregiver or patient may receive live coaching regarding suchadministration. Such instructions and prompts may be determined by theclinical trial manager to determine the success or failure of particularsets of instructions. Thus, not only are medications tested in such aclinical trial, but also sets of instructions are tested to determinewhich are best for all, or for giver demographic groups or the like foreventual user when the medication is released to the public, therebyallowing for a better adherence rate by the public. As the number ofclinical trials grows, and the locations of such trials becomes moreinternational, such administration through a system such as that setforth in accordance with the invention may become far more important tovarious clinical trial managers.

When following such instruction prompts, the actual act ofadministration is preferably captured as a video sequence at step 335.Thus administration preferably includes one or more identifiablegestures as suggested in accordance with the instructions above. Thus, apatient or administrator may be provided with one or more images orsequences for method of application or administration, and thus thefollowing of these sequences is used to determine compliance with aparticular prescribed regimen. Further, long gaps or pauses may bedetermined to give further insight into areas of administration that maybe giving problems to administrators of trial participants. Thiscaptured video sequence may be utilized in accordance with the inventionin a number of ways. First, the actions of administration of themedication is reviewed in real time and compared to an ideal or desiredvideo sequence. If a determination is made that the medication is beingadministered in an incorrect manner, and in a way that may bedetrimental to the patient, immediate warnings may be provided at step340 advising the caregiver or patient to stop administration at once.Furthermore, in extreme cases, a doctor or other caregiver may benotified, or in the most dangerous cases, an ambulance or otheremergency personnel may be dispatched to provide immediate care.Notification may also be provided to the clinical trial manager so thatthis person is warned that one or more patients are having problems withadherence with the protocol. If such problems turn out to be isolated,alternative instructions, or personal help may remedy the situation,thus allowing the person to provide meaningful data to the trial. Ifsuch lack of adherence is far more widespread, the clinical trialmanager may change instructions for all participants, or may even askall participants to come back in for further live instructions. Ineither situation, the cost of the clinical trial is greatly reduced asparticipants are able to remain in the study, and major failures ofstudies for lack of protocol adherence may be avoided. Reports basedupon such widespread lack of adherence may provide a manager with areport, using images or the like with identifying features removed sothat the report may show precisely how a medication is beingadministered while maintaining patient privacy and confidentiality. Ifvideo recording is not available, other confirmation methods as notedabove may be employed and be subject to automatic confirmation as withthe video recorded sequences.

If such immediate care or warning is not required, control then passesto step 345 where the video images are more formally captured andanalyzed for various other non-critical issues. The images may becaptured and stored locally, being provided to a central server in abatch processing, or images may be captured and sent to the remoteserver for immediate analysis and storage. Such transmission may takeplace over a well known Internet connection, wireless connection, orother proprietary communication system. Such analysis may considersuggestions to a caregiver to improve dosage accuracy, reduce pain inadministration, or the like. These suggestions may be implemented astweaks to various instruction or training sequences before themedication is released to the general public. Furthermore, as such videosequences may be available from multiple patients and/or caregiverstaking part in the current or multiple clinical trials, theeffectiveness of various sets of instructions and the like can be testedand reviewed, and changes thereto made if consistent problems areencountered. This type of study is nearly impossible without the presentinvention, because in any type of clinical setting, individuals are farmore likely to be careful in administration of medication, and thereforenot cause errors. When they return home or back to their regular lives,this is when adherence and administration issues arise. In accordancewith the invention, responses to instructions can be analyzed, and lackof adherence based upon confusing or difficult to follow instructionscan be remedied, providing better or more usable instructions, andtherefore improving regimen adherence. Without the present invention,such a clinical trial manager may be unaware of such issues. With theinvention, these issues can be addressed as they arise, thus ensuringthe integrity of the clinical trial.

In any event, after such analysis, any warnings or suggestions forinstruction issues may generate a warning at step 350, suggesting areasof instruction that may be problematic. These video sequences are alsostored for longer term analysis if desired at step 355, and processingends. Furthermore, in order to encourage patients in the clinical trial,notices of lack of adherence may be used to change remuneration receivedby a patient in the clinical trial. Thus, adherence to the protocolresults in higher payments to the patient, a great incentive for thepatient to adhere to the protocol.

Trends of a patient taking part in the clinical trial can be monitored,such as blood pressure or other measurable quantities of the patient,and correlation between such measured quantities and medicationadministration may be observed, potentially allowing for a morecustomized solution of medication to be applied to the patient, possiblemodifying dosage or frequency of administration based upon individualreactions to a particular prescription regimen. Additionally, featuresof the invention noted above allowing for user interaction andrecordation of activities of a user, adverse effects and the like may beincorporated into the system to provide further information fordetermining alternative instruction sets, modification of medicationsand the like.

It is further contemplated that the clinical trial manager be providedwith a manager dashboard allowing for summary review of all patientstaking part in one or more clinical trials. Details of an exemplaryembodiment of such a dashboard will now be described making reference toFIGS. 4-6. As is shown in FIG. 4, a summary page dashboard is shown at400. Each different clinical trial is contemplated to have one or moresummary pages (as more than one page may be necessary for a particularclinical trial given the number of participants). Each summary pageincludes indicators 410 for each participant taking place in aparticular clinical trial. In FIG. 4 such indicators are shown as iconsrepresenting each person. Such icons may be replaced with summaryidentification information or the like, or any other desired indicator,such a demographic indicators (i.e. age group, sex, medical condition,individual characteristics, etc.) Also included in dashboard 400 is anindicator legend including information that may be applied to any one ormore of the indicators 410. In this particular preferred embodiment ofthe invention, the indicator legend includes indicator modifiersrepresenting that a particular trial participant asked a question, has areport of poor compliance, or requested clarification of someinstruction or other facet of the clinical trial. As is shown, eachindicator modifier may be applied to a particular indicator 410 to whichthe modifier applies. Thus, as is shown in FIG. 4, indicator 412 hasbeen flagged for poor compliance, while indication 414 has been flaggedas asking a question. Thus, in this manner, a clinical trial manager isprovided with an overview of the status of the patients in a clinicaltrial. Major compliance problems would be easily determined by theclinical trial manager viewing a dashboard with many of the indicators410 being modified by the indicator modifier related to poor compliance.Similarly, problems with instructions might be apparent if the summarydisplay indicates a large number of questions or clarification requests.Of course indicator modifiers for any number of other situations may beprovided. Statistical analysis of the population of the clinical trialmay also be provided, thus allowing for the clinical trial manager todetermine adherence rates and other metrics of the entire or subsectionof the clinical trial population. Such modifiers are preferably colorindicators, but may comprise any other appropriate indication thatallows the clinical trial manager to determine status.

Dashboard 400 further preferably includes a zoom indicator that allowsthe clinical trial manager down to each patient or a smaller number ofpatients to view their overall compliance statistics, or to viewindividual recorded video sequences, requests for additionalinformation, or any other information stored as the audit trail forpatients in accordance with the invention. Thus, if the zoom indicatoris zoomed all of the way out, the clinical trial manager is presentedwith the largest number of indicators 410 on the dashboard. A mediumzoom preferably provides the clinical trial manager with a view such asthat shown in FIG. 5. As is shown, indicator 412 includes additionalinformation adjacent the indicator. In the displayed situation, the namefor the indicator modifier is shown. This may be beneficial when a largenumber of indicator modifiers may be provided. Alternatively, this textmight include a most critical piece of information, or a user selectedpiece of information. The zoom feature may also allow the clinical trialmanager to zoom down by demographic information of the like, thusviewing indicators 410 representing clinical trial participants havingsimilar characteristics in one form or another.

In addition, it is contemplated that the clinical trial manager may usethe summary dashboard, at any desired level of zoom, to select and move,modify, or otherwise act upon a subset of indicators included in aclinical trial. Thus, one or more participants may be assigned todifferent populations, grouped as desired to receive differentinstructions, dosages, or have any other modification of medicationadministration applied to the selected group of participants.Participants may also be grouped based upon prescribing medicalprovider, clinic, medical group, insurance company, or in any othermanner that might be considered useful to the clinical trial manager. Bygrouping by these groups, it may be possible to determine if anyparticular clinic, doctor or the like results in poor compliance forthat group. Thus, poor compliance linked to a particular such group canalso be addressed through, perhaps, additional training for the clinicor doctor. Participants may also be added to, or deleted from aparticular trial or other epidemiological study or the like, if desired,or otherwise manipulated. Groupings may also be automated, such asgrouping all patients by age, gender, or other demographiccharacteristic, thus providing a quick useful view to the clinical trialmanager.

Further zooming in allows the clinical trial manager to view a smallernumber of indicators, down to a single indicator. As the number ofindicators decreases, the amount of information available to theclinical trial manager for each indicator increases. Thus, the clinicaltrial manager may zoom down to one of the possible levels as shown inFIG. 6. As is shown in FIG. 6, the first zoom level shows the level ofinformation of FIG. 5, while a great number of indicators 410 are stillvisible. A more detailed zoom level preferably displays The same poorcompliance indicator, but further shows that this poor compliance isrelated to the medication schedule, and in particular a supply shortageof the medication, thus providing a more complete compliance check ofthe clinical trial participant. The information further provides poorcompliance information in that the participant represented by theindicator has not yet reviewed a required (or suggested) training video,and is also having difficulty with a fifth process in the definedconfirmation scheme. Finally, a further zoom level, after indication adesire to have more information regarding the poor compliance indicatesthat the participant has only had 7% of their actions confirmed byvideo, 10% confirmed by voice, and the remaining 83% confirmed by GUIinterface (which is patient dependent and therefore is not determined tobe as reliable as the other two methods). Furthermore, the participanthas asked a particular question. From this particular zoom level, it iscontemplated that the clinical trial manager may directly link to thestored video, audio or GUI provided information. Preferably, a timelineor the like is provided to the clinical trial manager indicating whenthe various, video, audio and/or GUI entries have been stored. Theclinical trial manager is able to view an even more useful picture ofthe sequence of compliance, and is then able to select any of the storedsequences for review. The manager may also answer the question, orforward the question to a physician or the like who is appropriate toanswer the question. The clinical trial manager may also opt to changeinstructions provided to one or more patients in accordance with theirrecord of adherence when being exposed to a first set of instructions.This level of zoom may also provide links for allowing communicationwith a particular participant, and method for suggesting additionaltraining, instructions or help, and a process for ordering or providingadditional medication to a participant. Specific instructions to apatient, preferences, or comments or the like provided by a patient mayalso be reviewed. Finally, the clinical trial manager may view upcomingprescription information, including times for taking a prescription orother medication administration applicable to one or more patients.

It is therefore through such a dashboard that the clinical trial managerreceives notice of any problematic failures on the part of patientswarranting intervention, either by direct contact, changes in regimen orinstruction, or recall of the patient for retraining. As noted above,rather than waiting for the patient to come back in and report pooradherence, or worse yet, allowing the patient data to become part of theclinical resultant data even with poor adherence, the clinical trialmanager may use the dashboard of the invention to ensure that poorcompliance is recognized early and dealt with. Furthermore, emergencysituations may be indicated to the clinical trial manager in animmediate manner.

Such a dashboard is preferably provided with patient management featuresin addition to the notification features noted above. Thus, the clinicaltrial manager is able to manage individual participants, subsets of thepopulation, or the entire population through drop and/or dragfunctionality, and is able to broadcast information to these groups asnecessary, including the broadcast of video, text, or voiceinstructions. The clinical trial manager may also preferably remindparticipants of upcoming doctor appointments, meetings regarding theclinical trial, and also provide such notices to the patient'sprescribing physician. Additional medication or supplies may be providedto a participant upon notice that they have run out, or merely trackingof medication actually taken by the participant. Thus, there is noguesswork. The manager may further review patient medical records, asnecessary, to further aid in trial procedure compliance.

The dashboard also preferably provides access to medical professionalsassociated with one or more of the clinical trial participants. In asituation where the trial provides all of the prescribing doctors orother medication administrators, for those patients that may needassistance, this feature may be trivial, but when multiple prescribingdoctors are involved in a trial, being able to forward information andinteract with these doctors may prove very valuable. Such contact may bemade through a link or connection provided associated with each patientidentifier icon on the dashboard. Thus, the clinical trial manager maybe able to review videos or other compliance indicia with such aprescribing physician, perform remote triage regarding any complicationsthat might arise with a patient during the course of the trial, orrequest prescription changes, etc. Furthermore, the clinical trialmanager may be able to audit these very medical professionals lookingafter, and administering medication in accordance with the prescribedclinical trial procedure. Through such an audit, the manager may be ableto determine issues related to actions of a particular administrator.

A user dashboard may also be provided to allow a participant to enterinformation, such as GUI entered compliance information as noted above,but also to ask questions, view additional instructions, order supplies,or the like. The user may view more specific prescription regimeninformation, such as when a next medication is scheduled to be taken, orbe provided with a calendar for a predetermined future time period toallow for future planning. Through such a user dashboard, the user mayview particular information relevant to their treatment, but preferablynot enough information to influence their participation in the trial. Ifin use, a participant may also view whether they have achieved variousadherence levels resulting in payments to be made to them in accordancewith the invention. Furthermore, the user may be provided with a methodfor determining a level of data transmission, including identityinformation that may be provided to various level of administrator.Thus, while all information may be provided to a clinical trial manager,perhaps more limited identifying information may be made available toother researchers or the like. The participant may be notified as topotential uses, and an opt in or opt out set of choices for suchdifferent levels of disclosure. The user may be provided with a privacysetting indicator to indicate a level of availability of recordedinformation and attachment of identifying information thereto.

Thus, provision of such a dashboard in conjunction with the operativeclinical trial verification process and system described above easesuse, increases effectiveness and allows for better control over such aclinical trial. Difficulties in following protocols may be determined innear real time. Changes in a trial may be easily implemented andconveyed to trial participants and their prescribing doctors. Newtraining modules, including video, written, or other instructions may beprovided during a trial in order to improve adherence. Inventorymanagement is eased and all trial participants are sure to have theappropriate amounts of medication and other supplies. Further, a fullaudit trail of who has accessed information for any particular patient,groups of patients, or one or more clinical trials is maintained. Thisdashboard, however, is not limited to use only in a clinical trial.Rather, the system can be used by a single medical provider, doctorgroup or network, insurance company, governmental agency, nursing home,hospice, home care provider or the like, or other group in order totrack any number of patients and associated home care workers, doctors,or other medication administrators. In such scenarios, the ability toview, group, and retrieve significant information about particularpatients allows for greater control over these patients, resulting inreduced likelihood of a patient continuing to take improper medication,or to improperly administer such medication, and therefore in turnreducing the possibility of an adverse reaction or death from aparticular medication.

A system provided in accordance with the invention includes imagingtechnology and hardware, communication hardware, computer systemsincluding storage memory and remote communication via the Internet orother communication network for remote storage and analysis, databasesof patient information and medication information sufficient toimplement the method as described above. All communications areencrypted or otherwise protected during transmission and storage at bothlocal and remote mass storage location to meet any security issues andany regulations required for the storage and maintenance of medical andpatient health care information.

Therefore, in accordance with the invention, a method and system areprovided that allow for the automated confirmation of adherence toadministration protocol for medication in a clinical trial environment,and provide for a most sophisticated method for confirming and studyingmethods of administration of such prescription medication.

It will thus be seen that the objects set forth above, among those madeapparent from the preceding description, are efficiently attained and,because certain changes may be made in carrying out the above method andin the construction(s) set forth without departing from the spirit andscope of the invention, it is intended that all matter contained in theabove description and shown in the accompanying drawings shall beinterpreted as illustrative and not in a limiting sense.

It is also to be understood that this description is intended to coverall of the generic and specific features of the invention hereindescribed and all statements of the scope of the invention which, as amatter of language, might be said to fall there between.

1. A method of confirming administration of medication in a clinicaltrial, comprising the steps of: identifying a particular medicationprescription regimen in accordance with the clinical trial; determiningone or more procedures for administering such prescription regimen inaccordance with the clinical trial; identifying one or more activitysequences associated with such procedures; capturing activity sequencesof actual administration of such prescription regimen; comparing thecaptured activity sequences to the identified activity sequences todetermine differences therebetween; and providing a notice ifdifferences are determined.
 2. The method of claim 1, wherein theprescription regimen is provided by a clinical trial manager.
 3. Themethod of claim 1, wherein the prescription regimen and procedures foradministering the prescription are retrieved from a medical database. 4.The method of claim 1, further comprising the step of performing astatistical analysis of differences determined in the comparing step. 5.The method of claim 1, further comprising the steps of: retrievingmedical history information of a patient to receive the administeredmedication subject to the clinical trial; and confirming that theadministered medication is safe for the patient.
 6. The method of claim1, further comprising the steps of: before capturing the one or moreactivity sequences of administration of the prescription regimen,determining the identity of a particular medication to be used in suchadministration; and issuing a warning if it is determined that thedetermined identity is not the medication associated with the upcomingprescription regimen.
 7. The method of claim 1, further comprising thesteps of: capturing activity sequences of actual administration of theprescription regimen during multiple instances of administration;comparing the captured activity sequences to the identified videosequences to determine differences therebetween; and providing ananalysis of adherence to a particular prescription regimen in accordancewith the multiple instances of administration.
 8. The method of claim 7,further comprising the step of providing additional instructions to amedication administrator in accordance with the provided analysis. 9.The method of claim 1, wherein the notice comprises live contact with aclinical trial manager.
 10. The method of claim 1, wherein the noticecomprises additional instructions to a patient receiving the medicationaccording to the one or more procedures of the clinical trial.
 11. Asystem for confirming administration of medication in a clinical trial,comprising: an authentication apparatus for authenticating a clinicaltrial manager; an input device for receiving information identifying aparticular medication prescription regimen from the authenticatedclinical trial manager; a database comprising prescriptionadministration information for the medication subject to the clinicaltrial, a storage device for storing prescription administration selectedfrom the database and being associated with the identified medicationprescription subject to the clinical trial, a set of instructions inaccordance with which the prescription regimen is to be administered,and one or more activity sequences associated with such instructions; acapture device for capturing activity sequences of actual administrationof such prescription regimen over a plurality of administrations of theprescription regimen; a processor for comparing the captured activitysequences to the identified activity sequences to determine differencestherebetween; and an output device for providing an immediate notice ifdifferences are determined in the comparing step that may place apatient receiving the prescription regimen in danger; and for providinga notice if differences are determined in the comparing step that mayimprove future administration of the prescription regimen in theclinical trial.
 12. The system of claim 11, wherein the informationstored on the storage device may be modified by the authenticatedclinical trial manager.
 13. The system of claim 11, wherein the capturedevice is further adapted to capture images of a particular medicationto allow identification thereof.
 14. A method of confirmingadministration of medication in a clinical trial, comprising the stepsof: authenticating a prescribing clinical trial manager; receivinginformation identifying a particular medication prescription regimenfrom the authenticated clinical trial manager; determining one or moreprocedures for administering such prescription regimen from one or moredatabases including prescription regimen information in accordance withprescription information provided by the authenticated clinical trialmanager; modifying the procedures, if necessary, by the authenticatedclinical trial manager; providing a set of instructions in accordancewith which the prescription regimen is to be administered; identifyingone or more indicia for determining confirmation of prescriptionadministration associated with such instructions; capturing appropriateindicia of actual administration of such prescription regimen over aplurality of administrations of the prescription regimen; comparing thecaptured indicia for determining confirmation of prescriptionadministration to the identified indicia for determining confirmation ofprescription administration to determine differences therebetween;providing an immediate notice if differences are determined in thecomparing step that may place a patient receiving the prescriptionregimen in danger; and providing a notice if differences are determinedin the comparing step that may improve future administration of theprescription regimen in the clinical trial.
 15. The method of claim 14,wherein the indicia for determining confirmation of prescriptionadministration comprises one or more activity sequences.
 16. The methodof claim 15, wherein the indicia for determining confirmation ofprescription administration comprises an alternative method whenactivity sequences may not be recorded.
 17. The method of claim 14,further comprising the steps of: capturing indicia of activity of apatient before medication administration; and providing a reminder tothe patient at least in part in accordance with the captured indiciabefore medication administration.
 18. The method of claim 14, furthercomprising the step of capturing indicia of activity of a patient beforemedication administration, wherein the captured indicia beforemedication administration comprises evidence of patient consent.
 19. Themethod of claim 14, further comprising the steps of: capturing indiciaof activity of a patient after medication administration; providingnotification to a medical service provider of the activity; andmodifying at least one aspect of a prescription regimen in accordancewith the captured indicia after medication administration.
 20. Themethod of claim 26, wherein the captured indicia after medicationadministration comprises an adverse reaction to the medication.
 21. Themethod of claim 21, further comprising the step of determining paymentsto a patient in a clinical trial based upon their level of compliance tothe prescribed regimen in the clinical trial.